A Double-Blind, Placebo-Controlled (Sham Surgery), Randomized, Multicenter Study Evaluating CERE-110 Gene Delivery in Subjects With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.
Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a "placebo" surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild to moderate Alzheimer's disease
- •Approved medications for Alzheimer's disease may be taken if the dose has been stable for 3 months
- •A study partner who can attend all study visits
- •Good general health
- •Medically able to undergo neurosurgery
排除标准
- •Significant neurological disease other than Alzheimer's disease
- •Significant depression or other psychiatric disorder
- •Unstable medical conditions
研究组 & 干预措施
Placebo
Placebo Surgery
干预措施: Placebo Surgery (Procedure)
结局指标
主要结局
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
时间窗: 24 Months
次要结局
- Neuropsychological Test Battery(24 Months)
- Mini-Mental State Examination (MMSE)(24 Months)
- Neuropsychiatric Inventory (NPI)(24 Months)
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)(24 Months)